FDA Waves a Big Stick

The US Food and Drug Administration is stepping up oversight and enforcement activity for medical products by advising industry to tighten its data integrity and quality-control measures to ensure compliance. A series of food-contamination crises (e.g., melamine in infant formula and salmonella in nut products) have raised charges of lax oversight of food quality and safety, and public polls indicate continued low confidence in the agency's ability to protect consumers from unsafe foods and drug products.

FDA's new leadership wants to turn that around. Principal Deputy Commissioner Joshua Sharfstein, who was FDA's acting commissioner pending confirmation of Margaret Hamburg for the top spot, took highly visible enforcement actions to illustrate that a new sheriff is in town. Soon after coming to FDA at the end of March, Sharfstein initiated a fast and aggressive recall of pistachio products as soon as evidence of salmonella contamination appeared. He also responded to criticism of FDA's process for regulating medical devices by supporting a review of safety information required for device classes.

Science & Swine Flu

The global swine influenza outbreak provided another opportunity for Sharfstein to take a proactive approach. He authorized emergency access to antiviral drugs and diagnostics and established teams under Jesse Goodman, newly named deputy commissioner for scientific and medical programs and acting chief medical officer, to facilitate the development of new vaccines, antivirals, diagnostics, and other products needed in a pandemic (see sidebar, "Science & Swine Flu").

Last month, FDA approved sanofi-pasteur's new Swiftwater, Pennsylvania, flu vaccine manufacturing facility, which can produce a new swine-flu vaccine if needed. In addition, a swine-flu consumer-protection team threatened fines and criminal action against anyone marketing products that make unapproved claims about guarding against or curing swine flu and seeking to take advantage of public fears about the virus.

Another new face at FDA reflects the agency's newly aggressive regulatory and legislative approach. David Dorsey, former top aide to Sen. Edward Kennedy (D-MA) on the Senate Health, Education, Labor, and Pensions (HELP) Committee, was named senior counsel to Sharfstein. Dorsey was a lead negotiator on legislation authorizing user fees, pediatric studies, and the Food and Drug Administration Amendments Act (FDAAA) of 2007. He also worked closely with Kennedy on proposals for authorizing biosimilars and for regulating dietary supplements.

"Enforcement will increase," warned Deborah Autor, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research (CDER), at the April annual meeting of the Food and Drug Law Institute (FDLI). She pointed to a rise in injunctions, investigator disqualifications, and Warning Letters and advised companies to avoid the big stick by "being proactive about compliance."

Attorney Jim O'Reilly predicted a visible shift from the "kinder, gentler" approach of the Bush administration to active monitoring of violative operations. Former FDA counsel Bob Spiller complained that "FDA civil enforcement was cuffed and curbed and starved over many years;" now he anticipates big changes with more resources available for enforcement efforts.

One sign of the times is an expansion in Autor's compliance office to 250 staffers from 150 five years ago. The growth increases FDA's ability to take regulatory action. CDER issued almost 40 Warning Letters between Jan. 1 and Apr. 14 of this year, nearly half of the 87 sent out in all of 2008. CDER's Division of Drug Marketing, Advertising, and Communications also sent notice-of-violation letters to 14 drug companies in early April charging that sponsored links on Internet search engines such as Google provide information about drug benefits without fully disclosing risks. Marketers objected that FDA was ignoring the communications capabilities of Internet technology, but consumer advocates supported the move as a way to ensure comparable disclosure of information on risks along with benefits.